This application proposes development of a unique resource designed to accelerate scientific progress - a National Research Database (NRDB) of Kaiser Permanente (KP) data that will contain clinical information on almost 30,000,000 current and past members of the Kaiser Foundation Health Plan in 8 regions of the country, with some data that spans a 40 year period. The database will be available to over 1,200 KP researchers, who are currently engaged in over 3,000 research projects, with a total funding of $60 million per year. Through data sharing mechanisms, a subset of the data will also be available to collaborating non-KP researchers. The need for a better research infrastructure is clear. Researchers are often frustrated by the difficulty of finding, extracting, cleaning, interpreting and transforming the data into useful analytical datasets. They often spend a disproportionate amount of time in these preparatory activities, rather than in the analytic phase of research projects. The primary reason for this is the absence of an efficient research data infrastructure that is optimized for the analytical needs of researchers. We have begun to develop such an infrastructure for the 3.3 million current and 10 million past Health Plan members in the KP Northern California region, in the form of a pilot Research Database (RDB). In this RDB, we have aggregated clinical data from legacy systems, the current electronic health record (EHR) system, various public use datasets, and research datasets into a research data warehouse. To develop the NRDB, four specific aims of the project will have to be achieved: 1) upgrade the pilot RDB by developing a uniform schema with consistent data definitions and coding, using standard terminology, that will harmonize aggregated legacy and current KP electronic health records, 2) develop interfaces and extract, transform and load (ETL) processes for the KP electronic medical record system and other clinical systems that will feed data to the NRDB, 3) implement a security model that is compliant with HIPAA and State regulations and KP policies, and 4) expand the pilot research database into a distributed database that will store data from the other seven KP regions. The NRDB will be a unique and valuable resource for clinical, epidemiological and health services research. It can be used in support of the health care goals of various government agencies (FDA, AHRQ, NIH), including comparative effectiveness research, biosurveillance, patient safety monitoring, post-marketing drug surveillance, geographical mapping of morbidity and mortality rates (by zip code or census tract), genetic and genomic studies, and many other types of research. Because KP has had some form of electronic health record for almost 40 years, the NRDB will provide a unique opportunity for researchers to study secular trends of disease, as well as following the health and disease status of large cohorts over time. PUBLIC HEALTH RELEVANCE: Kaiser Permanente (KP) has electronic health records (EHRs) on almost 30 million current and past members in 8 regions of the country. For the past 3 years we have been engaged in the creation of a pilot research database for KP Northern California, which constitutes about 1/3 of the health plan membership. The aim of this proposal is to enhance the pilot database, and expand it into a national research database (NRDB) that includes data extracted from the EHRs for all regions. The NRDB will be a unique and valuable resource for clinical, epidemiological and health services research. It will be available to over 1,200 KP researchers, who are currently engaged in over 3,000 research projects.